Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Phase I trial was performed at Ohio State University(OSU). Phase II, OSU was the coordinating center with other participating centers.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Women with metastatic breast cancer

Reporting Groups

Description

Treatment (Suramin and Paclitaxel)

PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Suramin and Paclitaxel (Phase I)

Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

Suramin and Paclitaxel (Phase II)

Patients receive paclitaxel in combination with the target dose of suramin.

Total

Total of all reporting groups

Baseline Measures

Suramin and Paclitaxel (Phase I)

Suramin and Paclitaxel (Phase II)

Total

Number of Participants
[units: participants]

9

22

31

Age
[units: years]Median (Full Range)

56
(44 to 73)

56
(35 to 70)

56
(35 to 73)

Gender
[units: participants]

Female

9

22

31

Male

0

0

0

Race (NIH/OMB)
[units: patients]

American Indian or Alaska Native

0

0

0

Asian

0

0

0

Native Hawaiian or Other Pacific Islander

0

0

0

Black or African American

1

3

4

White

8

19

27

More than one race

0

0

0

Unknown or Not Reported

0

0

0

Region of Enrollment
[units: patients]

United States

9

22

31

ECOG performance status (PS)
[1][units: patients]

ECOG PS 0

5

11

16

ECOG PS 1

4

8

12

ECOG PS 2

0

3

3

Menopausal status
[units: patients]

Premenopausal

0

1

1

Postmenopausal

9

21

30

ER/PR/HER 2 neu status
[units: patients]

ER+ or PR+ Status

6

14

20

HER2 neu+ Status

0

0

0

Triple negative Status

3

8

11

Number of sites of metastastic
[units: patients]

1

1

9

10

2

5

7

12

≥3

3

6

9

Sites of metastases
[units: patients]

Liver

3

12

15

Lung

6

10

16

Bone

6

11

17

Prior taxane therapy
[units: patients]

Paclitaxel

4

9

13

Docetaxel

5

10

15

Nab-paclitaxel

0

1

1

Paclitaxel and docetaxel

0

2

2

Prior chemotherapy (metastatic setting)
[units: patients]

0 Prior chemo therapies

5

0

5

1 Prior chemo therapies

10

4

14

2 Prior chemo therapies

7

3

10

3 Prior chemo therapies

0

2

2

[1]

0=Fully active, able to carry on all pre-disease performance without restriction.

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.